BRPI0817907B1 - Apparatus for administering a substance to an individual - Google Patents

Abstract

apparatus for administering a substance to an individual the present invention relates to an apparatus for administering a substance to an individual. a vial (22) contains the substance and a plug (24) is disposed within the vial and is slidably coupled to the vial. a first threaded element (26) is (a) rotatable with respect to the bottle and (b) substantially proximally immobilized with respect to the bottle during the rotation of the first threaded element. a second threaded element (28) is threadedly coupled with the first threaded element. at least one distal end of the second threaded element is substantially non-rotatable with respect to the flask, and the distal end of the second threaded element defines a coupling part (30) that couples the second threaded element to the plug. the first threaded element, by rotation, advances the plug linearly and at least the distal end of the second threaded element to a distal end (36) of the bottle. other modalities are also described.

Description

“APPLIANCE FOR ADMINISTERING A SUBSTANCE TO AN INDIVIDUAL" CROSS REFERENCES WITH RELATED REQUESTS

[001] The present application claims the benefit of U.S. Provisional Patent Application 60 / 997,459 to Gross et al., Filed on October 2, 2007, entitled "External Drug Pump", which is incorporated herein by reference.

[002] The present application relates to two U.S. patent applications, both entitled "External Drug Pump", to Gross and others, filed on the same date, which are incorporated herein by reference.

Field of the Invention [003] The present invention in general relates to an external medical device.

Specifically, the present invention relates to external medication pumps.

Background of the Invention [004] External drug pumps are typically used to deliver to patients substances that contain large molecules that cannot be digested when administered orally. They are commonly used to instill a basal rate of insulin in individuals suffering from diabetes, as an alternative to insulin injections through an insulin syringe or an insulin pen. Typically, the pump is attached to the patient's abdomen and delivers the substance to the patient through a cannula that is inserted into the patient's skin.

[005] U.S. patent 6,656,159 to Flaherty, describes a device for delivering fluid, such as insulin, for example, to a patient. The device includes an outlet orifice assembly, a syringe-like reservoir including a side wall extending to an outlet connected to the outlet orifice assembly. A threaded lead screw is received in the reservoir and a plunger has an outer periphery slidable along the side wall of the reservoir and an inner periphery received in a threaded way in the lead screw. The plunger is non-rotating with respect to the side wall such that the rotation of the lead screw is described as making the plunger advance into the reservoir and force the fluid through the outlet. The device also includes a dispenser having a return element for rotating the lead screw, and a shape memory element. A changeable length of the shape memory element decreasing from an unloaded length to a loaded length is described as restoring the return element.

[006] US Patent 6,699,218 to Flaherty, describes a device for delivering fluid to a patient, including a passageway having a proximal fluid transport tube, a distal fluid transport tube, a tubular expansion element coupling the tubes of fluid transport. A penetrating element is positioned within the expansion element for axial movement between the fluid transport tubes, and has a sharp distal tip. The device also includes a distributor for making the fluid from a reservoir flow to the proximal fluid transport tube, a housing containing the distributor and the passage and including an outlet port receiving the distal fluid transport tube, an element connected to the penetration element. The connecting element is movable by a user from an exterior of the housing and arranged such that the movement causes the penetrating element to move between an extended position to subcutaneously insert the distal fluid transport tube in a patient and a retracted position.

[007] U.S. patent 6,485,461 to Mason, describes a disposable device that is described as accurately and safely delivering an infusible liquid to a patient. The infusion device includes a housing that defines a bladder chamber. A compressible bladder is arranged in the bladder chamber and is compressed by the housing when filling the bladder with infusible liquid to create a pressurized bladder. Infusion devices also include a delivery system for subcutaneously dispensing the infusible liquid into a choir. The delivery system includes a detachable element that supports an injection needle and a cannula. The injection needle is used to insert the cannula into the skin of the body being treated. The cannula is in communication with the bladder during delivery of the infusible liquid. The housing includes microfluidic passages that allow communication between the fluid in the bladder and the cannula.

[008] Patent 5,851,197 to Marano, describes an injector for automatic placement of a subcutaneous or similar infusion set used to deliver a selected medication to a patient. The injector comprises a spring loaded plunger having a head to receive and support an infusion set in, a position for placing an insertion needle and related cannula through a patient's skin at a selected insertion site. The plunger head includes a safety locking mechanism described as engaging and retaining the infusion set during the spring loaded advance with a controlled force and speed for the patient's skin to transcutaneously insert the insertion needle and cannula. When the plunger head reaches a completely advanced position, with the infusion set placed on the patient, the infusion set is releasable from the safety lock mechanism with minimal force to allow quick and easy separation of the injector.

[009] U.S. Patent 6,960,192 to Flaherty, describes a device for delivering fluid to a person that includes a reservoir to hold a fluid to be delivered to the person; a fluid transport device for distributing fluid from the reservoir to the person, the fluid transport device including a proximal end in fluid communication with the reservoir and a distal end having a penetrating element to pierce the person's skin to facilitate the distribution of fluid by the person through the fluid transport device; a housing containing the reservoir and fluid transport device, the housing including an outlet port for receiving the distal end of the fluid transport device, the housing including an outlet port for receiving the distal end of the transport device of fluid in the injection of the distal end to the person and means for attaching a first wall of the housing to the person's skin; and an injection activation device including a drive mechanism contacting the fluid transport device to drive the penetrating element from a first position into the housing, through the outlet for a second position, external to the housing and inside the housing. person's skin.

[0010] U.S. Patent 6,905,298 to Haring, describes a nut assembly that will ensure that the axis of a screw featuring a measurable length and grip will pass through the contact plane of adjacent elements. The nut assembly also allows the desired compressible force on adjacent elements to be achieved using a telescopic aspect of the nut to locate the additional thread action for the screw, allowing the screw to be removed from inside the nut differently than would be allowed by a standard nut. The adaptability of the nut assembly can eliminate the need for washers or shims to adjust the screw shaft penetration. The nut assembly is useful for applications where the specified thread length and the grip length of the screw are incompatible with the limit thickness of the adjacent elements.

[0011] US Patent 1,795,630 to Wilson, describes a screw jack that uses a series of telescopic screw threaded sections that can be compactly arranged in the hollow base or jack housing when the jack is not in use, or when only a small space is available in which the jack must be used.

[0012] U.S. Patent 5,643,218 to Lynn et al., Describes a ring for sequential withdrawal of a first liquid and a second liquid. The syringe has a barrel, a proximal piston movable along the barrel to define a variable-volume chamber intermediate to the piston and the outer end of the barrel, and a distal chamber dividing piston to separate the volume chamber into primary and secondary reservoirs . A flow channel is defined along the syringe to provide a flow connection between the primary and secondary reservoirs. One element connects the two pistons so that when the proximal piston is moved away from the distal piston, the first liquid enters the first reservoir and after that the second liquid enters the secondary reservoir.

[0013] Daikyo Crystal Zenith® polymer, manufactured by Daikyo Seiko, Ltd., and used by Daikyo Seiko, Ltd. To manufacture flasks, it is described as being durable, non-scalable, highly transparent, very low in extractable ions, compatible with a wide pH range, and resistant to high heat.

[0014] Copaxone® (glatiramer acetate), manufactured by Teva Phar-maceutical Industries Ltd. is a drug described as helping patients suffering from recurrent-recurrent multiple sclerosis.

[0015] The following patent and patent application may be of interest: US Patent 6,749,587, to Flaherty US Patent Application Publication 2007/0118405, to Campbell Summary of the Invention [0016] In some embodiments of the invention, a vial containing a substance to be administered to an individual. The bottle is sealed by a plug, and has the first and second threaded elements (for example, a screw and a nut) that are threaded coupled together. The first threaded element is rotatable with respect to the bottle, and is linearly immobile with respect to the bottle during the rotation of the first threaded element. The rotating first threaded element is configured to linearly advance the plug and at least the distal end of the second threaded element to the distal end of the bottle, without substantially rotating the second threaded element and the plug. The distal end of the second threaded element defines a coupling part that couples the second threaded element to the plug.

[0017] In some embodiments, the stopper prevents the rotation of the second threaded element, for example, the friction between the stopper and the inside of the bottle prevents the rotation of the second threaded element. Alternatively or additionally, the bottle is shaped such that the bottle prevents the rotation of the second threaded element.

[0018] For some applications, the threaded elements are used in conjunction with a commercially available standard bottle and / or plug.

[0019] Typically, the distal end of the first threaded element is configured to remain proximal to the plug, or proximal to a distal end of the plug, and the proximal end of the second threaded element is configured to remain proximal to the distal end of the plug all sometimes during the rotation of the first threaded element.

[0020] Typically, the apparatus comprises a housing base, the flask and the threaded elements being configured to be inserted into or otherwise coupled to the housing base. For some applications, a portion of the housing base is configured to automatically move the threaded elements and the stop to a distal end of the bottle during insertion into the housing base.

[0021] In some modalities, the individual attaches a housing top to the housing base after the bottle is inserted into the housing base. The housing top typically contains a motor and a gear, the motor configured to rotate the gear and the gear configured to rotate the first threaded element. For some applications, a control unit administers a basal rate of the substance to the individual controlling the engine. Alternatively or in addition, the control unit is configured to receive an input and administer a bolus of the substance to the individual in response to the input.

Alternatively or alternatively, the control unit controls the administration of the substance to the individual in response to the detection by a sensor of one or more physiological parameters of the individual.

[0022] For some applications, the substance is administered to the individual through a cannula. The cannula typically surrounds a needle. The cannula is inserted into the subject's skin by piercing the subject's skin with the needle and inserting the needle. The needle is typically retracted from the individual's skin after piercing and the cannula remains inserted into the individual's skin for the duration of the time that the substance is administered to the individual.

[0023] In some applications, the device comprises a mechanism [0024] for activating skin perforation. The perforation of the individual's fur comprises rapidly piercing the individual's skin by displacing a force-receiving element from an activation mechanism. The application of a force to the activation mechanism that exceeds a limit force displaces the force receiving element. For example, the individual can press a button attached to the base or top of the housing, and, when applying force that exceeds the limit force, the needle is suddenly released, and quickly punctures the skin.

[0025] Note that the use of two separate parts, the housing top [0026] and the housing base, makes it easier to sterilize components that must be sterilized - particularly the fabric contact components of the base accommodation. The top housing, which typically comprises the battery, engine, and associated electronic devices, is typically not sterile.

[0027] Additionally, for the convenience of use by the individual, the top of the housing can be easily removed before bathing. Alternatively or in addition, all components at the top of the housing are waterproof, such that the top of the housing can remain attached to the bottom of the housing while the individual is bathing.

[0028] In some embodiments, the bottle comprises (for example, the bottle may be composed of) a cyclic olefin polymer, such as Crystal Zenith®.

[0029] It is therefore provided, according to one embodiment of the present invention, the apparatus for administering a substance to an individual, including: a vial containing the substance; a plug inside the bottle, slidably coupled to the bottle; a first threaded element (a) rotatable with respect to the bottle and (b) substantially immobile proximally with respect to the bottle during the rotation of the first threaded element; and a second threaded element that is threadedly coupled to the first element, at least one end of the second threaded element substantially non-rotating with respect to the flask, at the distal end of the second threaded element defining a coupling part that couples the second threaded element to the stopper, and the first threaded element, by rotation, linearly advancing the stopper and at least the distal end of the second threaded element to a distal end of the bottle.

In one embodiment, the apparatus also includes: a bottle housing unit that houses the bottle and the threaded elements; a needle housing unit coupled to the vial housing unit and not rigidly connected to the housing unit; a needle housed within the needle housing unit; and a cannula arranged at least partially around the needle, and the apparatus is configured to deliver the substance to the subject via the cannula.

[0030] In one embodiment, the distal end of the second threaded element [0031] is arranged at least partially within the plug.

[0032] In one embodiment, the second threaded element is configured to be coupled to the plug by a user.

[0033] In one embodiment, the second threaded element is provided to a user, the second threaded element already attached to the plug.

[0034] In one embodiment, the bottle includes a circular drum having an internal surface that is smooth.

[0035] In one embodiment, the substance includes insulin and the insulin is disposed within the vial.

[0036] In one embodiment, a distal end of the first threaded element remains proximal to a proximal end of the plug every time during the rotation of the first threaded element.

[0037] In one embodiment, the device also includes: a dividing plug inside the bottle, slidingly coupled to the bottle; vial includes a distal compartment and a proximal compartment, the distal compartment containing a powder and the proximal compartment containing a liquid, the dividing plug reversibly inhibiting the communication of fluid between the distal compartment and the proximal compartment, and the first threaded element, by rotation, mix the powder and the advanced liquid the splitting buffer to the distal end of the vial.

[0038] In one embodiment, the distal end of the second threaded element is configured to remain proximal to a distal end of the plug every time during the rotation of the first threaded element.

[0039] In one embodiment, the apparatus also includes a housing base, the flask and the first and second threaded elements are configured to be inserted in the housing base, and a part of the housing base is configured to prevent movement proximal linear axis of the first threaded element during the rotation of the first threaded element.

[0040] In one embodiment, the first threaded element includes a thread that defines a maximum diameter and a pitch, and a ratio between the maximum diameter and the pitch is 6: 1 to 15: 1.

[0041] In one embodiment, the friction between the cap and an internal surface [0042] of the bottle prevents the rotation of the second threaded element.

[0043] In one embodiment, the friction between the cap and an inner surface of the bottle prevents the rotation of the second threaded element while allowing the distal movement of the second threaded element.

[0044] In one embodiment, the device also includes a housing base, the flask and the first and second threaded elements are configured to be inserted into the housing base, and a part of the housing base is configured to move the threaded elements and the plug for the distal end of the bottle during insertion into the housing base.

[0045] In one embodiment, the part of the housing base is configured to apply sufficient force, when displacing the threaded elements and the plug, to overcome the friction between the plug and the bottle which is due to the prolonged storage of the plug in contact with the bottle.

[0046] In one embodiment, the device also includes a cannula attached to the base of the housing and configured to be inserted into the skin of the individual, and the base of the housing, displacing the threaded elements and the plug, is configured to expel gas through a distal end of the cannula.

[0047] In one embodiment, the part of the housing base, displacing the threaded elements and the plug, is configured to expel at least some of the substance through the distal end of the cannula.

[0048] In one embodiment, the part of the housing base is arranged with respect to a part at a proximal end of the bottle such that, during the insertion of the bottle and the threaded elements in the housing base, the relative movement between the part of the housing base and the part at the proximal end of the bottle displaces the threaded elements and the plug towards the distal end of the bottle.

[0049] In one embodiment, the part of the housing base is arranged such that the sliding movement between the part of the housing base and the part at the proximal end of the bottle advances the threaded elements and the plug towards the distal end of the bottle.

[0050] In one embodiment, the device also includes: at least one gearwheel that is attachable at a proximal end of the first threaded element and configured to rotate the first threaded element by rotation; a motor configured to rotate the sprocket; and a housing top, to which the sprocket and motor are coupled.

[0051] In one embodiment, the device also includes a control unit coupled to the engine, and the control unit is configured to receive a coded indication of a characteristic of the substance, and to control the engine in response to the indication of the characteristic of the substance.

[0052] In one embodiment, the device also includes a control unit coupled to the engine, and the control unit is programmable and is configured to be programmed to administer a basal rate of the substance in the individual controlling the engine.

[0053] In one embodiment, the device also includes a control unit coupled to the engine, and the control unit is configured to receive an entry and to administer a bolus of the substance to the individual in response to the entry.

[0054] In one embodiment, the device also includes: a control unit coupled to the engine; and a sensor configured to detect an individual's physiological parameter and transmit a signal to the control unit in response to the parameter, and the control unit is configured to control the engine in response to the signal.

[0055] In one embodiment, the sensor is configured to be implanted in the individual's body.

[0056] In one mode, the sensor is configured to transmit the signal wirelessly.

[0057] In one embodiment, the device also includes a housing base configured to hold the vial, and the housing base and the housing top are configured to be coupled together by the individual before administration of the substance, and uncoupled one of the other by the individual after administration of the substance.

[0058] In one embodiment, the top of the housing is configured to be reused subsequent to the administration of the vial substance, and the housing base and the threaded elements are configured to be discarded following the administration of the vial substance.

[0059] In one embodiment, the device also includes: one or more magnetic elements coupled to the base of the housing, and one or more magnetic elements coupled to the top of the housing; and the magnetic elements are configured to couple the base of the housing at the top of the housing when the base of the housing and the top of the housing are aligned.

In one embodiment, the apparatus also includes: a housing base, and the bottle and threaded elements are configured to be inserted into the housing base; a needle attached to the housing base; and a cannula at least partially arranged around the needle, the needle is configured to puncture the subject's skin and insert the cannula into the subject's skin, the needle is configured to retract after puncture, and the apparatus is configured to deliver the substance in the individual through the cannula.

[0060] In one embodiment, the device also includes a needle activation mechanism coupled to the needle, the needle activation mechanism including: [0061] a contact surface with the individual for application of a force by the individual; and [0062] a force receiving element that is configured to be displaced when the force applied by the individual on the contact surface with the individual exceeds a limit force, and [0063] the needle is configured to quickly pierce the skin in response to displacement of the force receiving element due to the force exceeding the limit force.

[0064] In one embodiment, the device still includes a spring, and the spring is configured to retract the needle after drilling.

[0065] In one embodiment, the device also includes: a housing base, the bottle and the threaded elements being configured to be inserted into the housing base; and a needle attached to the housing base and configured to pierce the individual's skin, and the apparatus is configured to deliver the substance to the individual via the needle.

[0066] In one embodiment, the device is configured to deliver substantially all of the substance in less than an hour.

[0067] In one embodiment, the substance includes glatiramer acetate in the individual via the needle.

[0068] In one embodiment, the device also includes: a housing base, the bottle and the threaded elements being configured to be inserted in the housing base; and a plurality of microneedles coupled to the base of the housing and configured to pierce the individual's skin, and the apparatus is configured to deliver the substance to the individual by means of the plurality of microneedles.

[0069] In one embodiment, the diameter of each microneedle is less than 150 microns.

[0070] In one embodiment, the first threaded element includes a screw, and the second threaded element includes a nut at least partially arranged around the screw.

[0071] In one embodiment, the screw includes a telescopic screw, and the screw is configured to advance a distal end of the nut to the distal end of the bottle by extending the telescopic screw to the distal end of the bottle.

[0072] In one embodiment, the telescopic screw includes two parts at least partially overlapping.

[0073] In one embodiment, the telescopic screw includes three or more parts at least partially overlapping.

[0074] In one embodiment, the nut includes a telescopic nut, and the screw is configured to advance a distal end of the nut to the distal end of the bottle by extending the telescopic nut to the distal end of the bottle.

[0075] In one embodiment, the telescopic nut includes two parts at least partially overlapping.

[007 6] In one embodiment, the telescopic nut includes three or more parts at least partially overlapping.

[0077] In one embodiment, the first threaded element includes a [0078] nut, and the second threaded element includes a screw at least partially disposed within the nut.

[0079] In one embodiment, the screw includes a telescopic screw, and the nut is configured to advance a distal end of the screw to the distal end of the bottle by extending the telescopic screw to the distal end of the bottle.

[0080] In one embodiment, the telescopic screw includes two more overlapping parts, at least partially.

[0081] In one embodiment, the telescopic screw includes three or more parts at least partially overlapping.

[0082] In one embodiment, the nut includes a telescopic nut, and the nut is configured to advance a distal end of the screw to the distal end of the bottle by extending the telescopic nut to the distal end of the bottle.

[0083] In one embodiment, the telescopic nut includes two parts at least partially overlapping.

[0084] In one embodiment, the telescopic nut includes three or more overlapping parts, at least partially.

[0085] In addition, according to the modality of the present invention, a method is included which includes: providing a vial containing a substance, which is sealed by a plug, and first and second threaded elements for placement inside the vial, the first and second threaded elements being threadedly coupled to each other, a distal end of the second threaded element being to engage the plug, insert the bottle into a base housing, the threaded elements having been inserted into the bottle, and the end distal from the second threaded element having been coupled to the plug; and expel the substance from the advanced bottle the cap and at least the distal end of the second threaded element to a distal end of the bottle, the advance being made: turning the first threaded element with respect to the bottle, preventing the proximal linear movement of the first threaded element with respect to the bottle during the rotation of the first threaded element, and preventing rotational movement of at least the distal end of the second threaded element with respect to the bottle.

[0086] In addition, according to one embodiment of the present invention, the apparatus for administering a substance to an individual is included, including: a vial containing the substance; a plug inside the bottle, slidably coupled to the bottle; a stem inside the bottle, a distal part of the stem being coupled to the plug; and a rotation mechanism arranged proximal to the vial, coupled to the stem and configured to linearly advance the plug to a distal end of the vial by rotating the stem, and at all times during the rotation of the shaft, (a) a distal end the stem is configured to remain proximal to (b) a distal end of the plug, and a proximal end of the stem is configured to remain distal to a proximal end of the rotation mechanism.

[0087] In addition, according to an embodiment of the present invention, a method is included which includes: providing a vial containing a substance, is sealed by a plug, and has a rod which is coupled to the plug; insert the bottle into a housing base, a rotation mechanism being coupled to the housing base proximal to the stem; and expel the substance from the bottle by advancing the plug by turning the stem; keeping a distal end of the nail proximal to a distal end of the plug every time during nail rotation; and maintaining a proximal end of the nail distal to a proximal end of the rotation mechanism every time during the rotation of the nail.

[0088] It is also provided, according to one embodiment of the present invention, the apparatus for administering a substance to an individual, including: a vial containing the substance; a plug inside the bottle, slidably coupled to the bottle; a first threaded element (a) rotatable with respect to the bottle and (b) substantially immobile proximally with respect to the bottle 20 during rotation of the first threaded element; and a second threaded element which is threadedly coupled to the first threaded element, at least one distal end of the second threaded element substantially non-rotating with respect to the flask, the distal end of the second threaded element remaining proximal to a distal end of the plug times during the rotation of the first threaded element, and the first threaded element, by rotation, linearly advancing the plug and at least the distal end of the second threaded element to a distal end of the bottle.

[0089] In addition, according to one embodiment of the present invention, a method including providing: a vial that contains a substance, and is sealed by a plug, and first and second threaded elements for placement inside the vial, the first and second threaded elements being threadedly coupled to each other, a distal end of the second threaded element being to engage the plug, insert the bottle into a base housing, the threaded elements having been inserted into the bottle, and the distal end of the second threaded element having been coupled to the plug; and expel the substance from the advanced bottle the cap and at least the distal end of the second threaded element to a distal end of the bottle, the advance being made: turning the first threaded element with respect to the bottle, preventing the proximal linear movement the first threaded element with respect to the bottle during the rotation of the first threaded element, and preventing rotational movement at least from the distal end of the second threaded element with respect to the bottle; and keeping the distal end of the second threaded element proximal to a distal end of the plug every time during the rotation of the first threaded element.

[0090] The present invention will be more fully understood from the following detailed description of its modalities, taken together with the drawings.

Brief Description of the Drawings [0091] Figure 1 A is a schematic illustration of an apparatus for administering a substance to an individual, according to an embodiment of the present invention; figure 1 B is a schematic illustration of the apparatus of figure 1 A on a subject's body, a sensor for use with the apparatus being disposed within the subject's body, according to an embodiment of the present invention; figure 2 is a schematic exploded view of the apparatus of figure 1, according to an embodiment of the present invention; figure 3 is a schematic illustration of a housing base of the apparatus of figure 1, according to an embodiment of the present invention; figure 4 is a schematic illustration of a bottle being inserted into the housing base of figure 3, according to an embodiment of the present invention; Figure 5A is a schematic illustration of a bottle inserted in the housing base, according to an embodiment of the present invention; figure 58 is a schematic illustration of a housing top coupled to the housing base, according to an embodiment of the present invention; figures 6A-D are schematic cross-sectional illustrations, taken along line VI of figure 5A, of the bottle in the respective stages of use of the device, according to an embodiment of the present invention; figure 6E is a force vector diagram showing the forces acting on a plug during the operation of the apparatus, according to an embodiment of the present invention; figures 7A-C are schematic cross-sectional illustrations, taken along line VII of figure 5A, of an apparatus activation mechanism at respective stages of operation of the apparatus, according to an embodiment of the present invention; figures 8A-B are schematic illustrations of a bottle, according to an embodiment of the present invention; Figures 9A-B are schematic illustrations of a two-chamber flask, according to an embodiment of the present invention; Figures 10A-8 are schematic illustrations of a double-chambered flask, according to an alternative embodiment of the present invention; figure 11 is a schematic illustration of a bottle, according to an embodiment of the present invention; Figure 12A-B are schematic illustrations of a bottle containing a telescopic screw, according to the respective modalities of the present invention; figure 13 is a schematic illustration of a bottle containing a telescopic nut, according to an embodiment of the present invention; and figure 14 is a schematic illustration of the apparatus including a vial housing unit and a separate needle housing unit, according to an embodiment of the present invention.

Detailed Description of the Modalities [0092] Reference is now made to Figures 1 A-8 and 2, which are schematic illustrations of the apparatus 20 for administering a substance, for example, insulin, to an individual, according to a modality of the present invention. dog. Typically, apparatus 20 comprises a vial 22 containing the substance to be administered to an individual. The flask 22 is sealed at its proximal end by a plug 24. A first threaded element 26 (e.g., a screw, as shown) is arranged at least in part within the bottle, threadedly coupled to the first threaded element. The distal end of the second threaded element defines a coupling part 30 that couples the second threaded element to the plug. The first threaded element is rotated by a rotation mechanism (for example, motor 50), and by rotation, the second threaded element and the cap linearly advances to a distal end of the bottle, without substantially rotating the second threaded element or the plug.

[0093] In some embodiments, the first threaded element 26 is a nut and the second threaded element 28 is a screw disposed at least in part within the nut. The nut is configured to turn and make the screw and the cap advance to a distal end of the bottle due to the rotation of the nut. Alternatively, the first threaded element is a first screw and the second threaded element is a second screw. The first screw is configured, by rotation, to advance the second screw and the plug to the distal end of the bottle. In general, the apparatus 20 comprises a first rotating threaded element, but is substantially linearly immobile during rotation of the first threaded element, a second threaded element which (a) is substantially non-rotating, (b) moves linearly to the distal end the bottle in response to the rotation of the first threaded element, and (c) is coupled to the plug. The first threaded element is rotated, making the second threaded element and the plug advance distally.

[0094] Typically, vial 22 is inserted into a housing base 32. In some embodiments, part 34 of the housing base is configured to prevent proximal linear movement of the first threaded element 26. (In the context of the application for present patent and in the claims, the term "proximal" indicates a position towards an end 38 of the vial. The term "distal" indicates a position towards the end 36 of the vial, out of which the substance is administered to the subject). In some embodiments, during the rotation of the second threaded element 28. Typically, the friction of the plug against the inside of the bottle prevents the rotational movement of the plug, and the element 28 being coupled to the plug is similarly prevented. Thus, when the first threaded element 26 is rotated, the second threaded element 28 and the plug advance linearly to the distal end 36 of the bottle. In some embodiments, a standard commercially available flask and tampon are used as flask 22 and plug 24. For some applications, the first and second threaded elements are standard threaded elements, commercially available, for example, a commercially available standard bolt and nut. The friction between the cap and the bottle prevents the cap from rotating, while allowing the distal movement of the plug inside the bottle. As described in further detail here below, with references to figures 6C and 6E.

[0095] For some applications, the rotation of the second threaded element is prevented by other means, for example, as described here below.

[0096] For some applications, the initial position of buffer 24 in bottle 22 is according to the amount of the substance that is contained within the bottle and that must be administered to the individual. The lengths of the first and second threaded elements 26 and 28 are typically such that when the threaded parts of the elements are overlapping maximally (ie completely screwed together), and the elements are arranged inside the bottle, the coupling part 30 engages the second threaded element in the plug. For example, the lengths of the bolt and nut, shown in figure 2, are typically such that when the bolt is inserted maximally into the nut, the bolt and nut are arranged inside the jar, the coupling part 30 of the nut couples the nut to the cap. For example, if the vial contains a small amount of the substance before administering the substance, then the plug is disposed towards the distal end 36 of the vial. In such a case, a relatively long screw / nut assembly (or screw / screw assembly) is designed to be arranged within the bottle, so that the coupling part 30 engages the nut in the plug. If, on the other hand, a large volume of the substance is contained within the bottle, then a relatively short screw / nut assembly (or screw / screw assembly) is color-coded or otherwise marked to indicate that the assembly screw / nut (or screw / screw assembly) is suitable for use with this initial volume of the substance.

[0097] In an alternative embodiment, the first and second threaded elements 26 and 28 are placed in the bottle, without being selected based on the initial volume of the substance, and the elements are unscrewed from each other in an adequate amount in order to facilitate the coupling the coupling part 30 to the plug.

[0098] Typically, a distal end 40 of the first threaded element 26 is configured to remain proximal to the plug, or proximal to the distal end 43 of the plug, each time during the rotation of the first threaded element. Thereafter, typically, the distal end of the second threaded element remains proximal to the distal end of the plug every time during the rotation of the first threaded element. The plug typically provides a seal between a first part of the flask, which is distal to the plug, and a second part of the flask, which is proximal to the plug. In some embodiments, the sterility of the substance disposed in the first part is maintained by the plug providing a seal between the first part and the second part, the threaded elements being arranged in the second part. The assembly of the first and second threaded elements can be viewed as a rod that converts the rotational movement of the motor 50 into a distal advance of the plug 24. Typically, every time during the rotation of the rod, (a) the distal end of the rod (ie that is, the distal ex-tremity of the second threaded element) is configured to remain proximal to a distal end of the plug, and (b) the proximal end of the stem (i.e., the proximal end of the first threaded element) is configured to remain distal to a proximal end of the rotation mechanism.

[0099] For some applications, a flask piercing mechanism 44 is movably coupled (for example, rotatably) to the base of the housing 32. As part of the insertion of vial 22 into the housing base, a seal 46 at the distal end 36 of the bottle is pierced by pressing the seal against the piercing mechanism. The substance is configured to subsequently flow through a tube 52 to an activation mechanism 56, which is typically coupled to the housing base, and is configured to insert a cannula and / or a needle through the subject's skin and to deliver the substance through the cannula and / or the needle.

[00100] Although the first and second threaded elements 26 and 28 have been described as being inside the bottle 22 (for example, the device can be placed by the individual with the threaded elements already inside the bottle), in some modalities , the threaded elements are inserted into the bottle and are coupled to the .24 plug by the individual and / or a nursing assistant. In some embodiments, flask 22 and plug 24 are a standard commercially available flask and plug, for example, the flask may be a circular barrel with a smooth inner wall. The first and second threaded elements are inserted into the bottle and attached to the plug, and the device distributes the substance, according to the techniques described here above. The friction between the standard plug and the standard bottle prevents the second threaded element from rotating due to the coupling of the second threaded element with the plug, as described here above. For some applications, providing the apparatus described here for use with standard, commercially available bottles and plugs provides a commercial advantage.

[00101] For some applications, the threaded elements are coupled to the housing base 32, and the individual and / or nursing assistant moves the flask with respect to the base of the housing in order to couple the plug to the second threaded element. For example, a standard commercially available flask and plug may be moved with respect to the base of the housing, in order to couple the plug to the second threaded element, the threaded elements being coupled to the base of the housing.

[00102] In some embodiments, a housing top 48 is coupled by the individual to the housing base 32. The housing top typically comprises a motor 50 and a battery 58. (in one embodiment, the battery is coupled to the housing base 32 ). For some applications, a first sprocket 52 is coupled to the housing base 32. The motor is configured to rotate the sprocket, and the sprocket is configured to rotate the first threaded element 26. Typically, the first wheel gear 52 engages a second gear 54, the second gear being coupled to the proximal end of the threaded element 26, and / or comprising the proximal part of the threaded element 26. In some embodiments, only a single gearwheel is used, the single gearwheel being coupled to and / or comprising a proximal part of the threaded element 26, and the single gearwheel being turned directly by the motor. Alternatively or in addition, other techniques known in the art are used to convert motion of an engine into rotational or linear motion.

[00103] For some applications, the individual reversibly couples the top of the housing to the base of the housing 32. Following the thermal distribution of the substance to the individual from the vial 22, the individual and / or nursing assistant uncouples the top of the base housing. In some embodiments, the top of the housing is configured to be reused with another housing base, and the housing base is configured to be discarded after a single use. For some applications, the top of the housing and the base of the housing comprise magnetic materials 59 which are configured to releasably couple the top of the housing to the base of the housing when the top and base are aligned.

[00104] For some applications, a control unit 51 is coupled to the engine 50. In some embodiments, the control unit administers a basal rate of the substance in the individual controlling the engine. Alternatively or additionally, the control unit is configured to receive an input and administer a bolus of the substance to the individual in response to the input. For example, the top of housing 48 may comprise two buttons. When both buttons are pressed at the same time, the control unit is configured to deliver a bolus of medication. Alternatively, a button 80 associated with activation mechanism 56 can be configured to make the control unit deliver a bolus of the medication when pushed subsequent to the insertion mechanism having been activated. Alternatively or in addition, a sensor 57 (shown in figure 18) is configured to detect one or more physiological parameters of the individual. The control unit is configured to control the administration of the substance in response to the detected parameters. In some modalities, the sensor is configured to be implanted in the individual. For some applications, the sensor transmits the detected parameters to the control unit wirelessly.

[00105] In some embodiments, vial 22 has a distal compartment that contains a powder, and a proximal compartment that contains a liquid. The distal compartment and the proximal compartment are reversibly separated by a divider plug 134 (shown in figures 9A-B). The first threaded element 26, by rotation, mixes the powder and the liquid by advancing the dividing plug towards the distal end 36 of the flask, as described in detail here below, with reference to figures 9A-B.

[00106] Reference is now made to Figures 3 and 4, which are respectively a schematic illustration of the housing base 32, and a schematic illustration of the bottle 22 being inserted into the housing base, in accordance with an embodiment of the present invention. The housing base, as shown in figure 3, is prepared for insertion of the vial 22. The distal end of the vial is inserted into the perforation mechanism of vial 44, which pierces the seal at the distal end of the vial. The vial is then lowered into the housing base. Typically, opposing resilient arms 70 support the vial on the housing base.

[00107] In some embodiments, when the bottle is lowered into the housing base 32, the first gear wheel 52 engages the second gear wheel 54. For some applications, when the bottle is lowered, part 34 of the housing base automatically shifts the first and second threaded elements 26 and 28 (and therefore the plug 24) to the distal end 36 of the bottle. In some embodiments, the plug is disposed within the bottle such that before inserting the bottle into the housing, the first threaded element 26 projects a distance h from the proximal end of the bottle. The proximal end of the first threaded element (or the second sprocket 54) comprises a rounded part 7 4. The housing base part 34 comprises an inclined face 76. When the air-rounded part 7 4 slides past the inclined face , the first threaded element is pushed the distance h into the bottle. As a result, the threaded elements and the plug are moved to the distal end of the bottle.

[00108] In some embodiments, the apparatus 20 comprises alternative means of pushing threaded elements 26 and 28 into the bottle 22 during insertion of the bottle into the housing base 32. For example, the proximal end of the first threaded element 26 may comprise an inclined face and the part 34 of the housing base can comprise a rounded part. Alternatively, the proximal end of the first threaded element and the housing portion 34 may comprise an inclined face and / or a rounded portion.

[00109] For some applications, the part 34 of the housing base 32 is configured to apply a sufficient force, when displacing the threaded elements 26 and 28 and the plug 24, to overcome the friction between the plug 24 and the bottle 22 which is due to the prolonged storage of the buffer in contact with the vial. For example, the plug may be stored in contact with the inner surface of the bottle for a period of at least a week or longer, as a result of which the plug may have a greater effective static friction than would have existed if the plug had recently been removed with respect to the vial. Alternatively or additionally, the apparatus 20 comprises a cannula 100 and / or a needle 102 (as shown in figures 7A-C), configured to be inserted into the subject's skin. The part 34 of the housing base, displacing the threaded elements and the plug, is configured to expel gas through a distal end of the cannula and / or needle. In some embodiments, in addition to expelling gas, part 34 is configured to expel some of its substance as a result of displacement of the threaded elements and the plug. Typically, the expulsion of the substance from the distal end of the cannula before the cannula is inserted into the individual's skin increases the accuracy of the first dosage administered, because the initial activation of the engine essentially administers the substance immediately, without previously ejecting the stored gas. -nothing in the bottle or conduits of the appliance 20.

[00110] Reference is now made to figures 5A and 58, which are respectively a schematic illustration of the bottle 22 inserted in the housing base 32, and the housing top 48 coupled to the housing base 32, according to an embodiment of the present invention. . The housing top 48 is shaped such that when it is attached to the housing base, the button 80 of the activation mechanism 56 is accessible to be pressed by the individual.

[00111] Reference is now ugly to figures 6A-E. Figures 6A-D are schematic cross-sectional illustrations of vial 22 at respective stages of use of the apparatus 20, according to an embodiment of the present invention. Figure 6E is a force vector diagram showing the forces acting on the plug 24 during the rotation of the first threaded element 26, according to an embodiment of the present invention.

[00112] Figure 6A shows the flask 22 prior to its insertion into the housing base 32. The first threaded element 26 (for example, a screw, as shown) projects by the distance h from the proximal end 38 of the flask. The second threaded element 28 (for example, a nut, as shown) is threadedly coupled to the first threaded element and is coupled to the plug 24 by means of the coupling part 30. For example, the coupling part 30 can be shaped to set teeth 90, which are inserted into the plug. Or, the coupling part 30 can be a flat surface that is flush with a proximal end 42 of the plug 24, or that is otherwise in contact with the plug.

[00113] During insertion of the bottle in the housing base, the first and second threaded elements and the plug are moved to the distal end 36 of the bottle, as shown in figure 68.

[00114] The first threaded element 26 rotates during the administration of the substance to the individual. The rotational movement of the second threaded element 28 is prevented (even if not necessarily eliminated) by the plug 24 in which the second brushed element is coupled, and / or rotational movement of the second threaded element is prevented by alternative means, for example, as described with reference to figures 8A-B. In addition, the proximal linear movement of the first threaded element with respect to the bottle is prevented (by the part 34 of the housing base 32, not shown) during the rotation of the first threaded element. The rotation of the first threaded element combined with the impeded rotation of the second threaded element results in the second threaded element and the plug advancing to the distal end 36 of the bottle 22, as shown in figures 6C and 60.

[00115] Typically, due to the rotation of the first threaded element, a linear force FL and a rotational force FR act on the plug 24, as shown in figure 6E. A frictional force FFL between the cap and the vial 22 acts to oppose the linear advance of the cap, and the rotational frictional force FFR between the cap and the vial acts to oppose the rotation of the tampon. Still typically, and as described in detail in the following paragraphs, the friction between the cap and the flask acts to oppose the rotation of the plug to a greater extent which acts to oppose the linear advancement of the plug through the flask. In particular, in this embodiment, the rotation of the plug (for example) by a complete rotation is prevented to a much greater extent than the advance movement of the plug by the pitch of the threaded elements is prevented, because significantly more friction must be overcome to produce a complete rotation of the plug that would be necessary to be overcome in order for the plug to advance the step distance of the threaded elements. As a result, the friction generally acts to prevent the rotation of the plug, while following the movement of the plug within the bottle.

[00116] In a more detailed analysis of this effect, it is noted that, in some modalities, the friction between the cap and the vial has the effect mentioned above due to the selection of an appropriate ratio of (a) the maximum diameter D of the first threaded element (shown in figure 6C) to (b) step P of the first threaded element. Typically, the ratio of the maximum diameter D to step P is 3: 1 to 30: 1, for example, 6: 1 to 20: 1, or 8: 1 to 15: 1. In some embodiments, the ratio is 6: 1 to 15: 1, for example, 10: 1. The pitch of the second threaded element is the same as the pitch of the first threaded element. The proximal linear movement of the first threaded element is prevented (as described here above). Therefore, when the first threaded element rotates and the second threaded element unscrews the first threaded element, the second threaded element must both rotate, advance distally, when rotate and advance distally.

[00117] By way of example, the first threaded element can have a maximum diameter of 8 mm and a pitch of 1 mm (that is, a maximum diameter ratio to the pitch of 8: 1). Consequently, the outer perimeter of the first threaded element is greater than 25 mm (pi multiplied by the maximum diameter). When the first threaded element rotates through 360 degrees, if the second threaded element were to be unscrewed from the first threaded element by rotation, the second threaded element would rotate over a distance of more than 25 mm, around the perimeter of the first threaded element . Consequently, the outer surface of the plug would rotate in contact with the inner surface of the bottle over a much greater distance, such as 40 mm (since the outer diameter of the plug is greater than that of the first threaded element, as seen, for example, in any of Figures 6A-D). Alternatively, if the second threaded element unscrews the first threaded element by linearly advancing through the bottle, it advances a distance of 1 mm, that is, by a distance that is equal to the pitch of the threaded elements. Consequently, in the presence of intentionally generated, significant friction, the tampon advances substantially only in a linear fashion (in contact with the inner surface of the bottle) by a distance of 1 mm, while rotating only for a relatively small extent.

[00118] It is noted that in some modalities, the friction between the plug and the bottle acts to prevent the rotation of the plug, while allowing the distal movement of the plug inside the bottle, generally independent of the relationship of the maximum diameter D with step P of the first threaded element.

[00119] As described here above, in some embodiments, friction acts to prevent the rotation of the plug, while allowing the distal movement of the plug inside the vial, even when the apparatus described here is used in conjunction with vials, plugs, and standard threaded elements, commercially available.

[00120] Reference is now made to figures 7 A-C, which are schematic illustrations of the activation mechanism 56 of the apparatus 20 in the respective stages of operation of the device, according to a modality of the present invention. Typically, following the insertion of the vial 22 into the housing base 32, and the coupling of the housing top 48 with the housing base, the bottom surface of the housing base is adhered to the subject's skin (for example, with an adhesive ), as shown in figure 1 B. Subsequently, the activation mechanism is activated.

[00121] Figure 7 shows the activation mechanism 56 before the activation mechanism was activated. Needle 102 is disposed within the activation mechanism, and cannula 100 is disposed around the exterior of the needle. When the surface and bottom of the housing base 32 are adhered to the individual's skin, the individual pushes the button 80, which is accessible through the top of the housing, as shown in figure 58. Until the push force of the button exceeds a force limit, the friction between a protrusion 104 of a structural element 103 and the force receiving element 106 prevents the button and needle from being pushed down. (The force receiving element 106 is typically a surface of a retaining part 108, described here below). When the button is pushed by the subject with a force that exceeds the limit force, the force receiving element 106 is suddenly and quickly pushed aside by protrusion 104. Typically, applying sufficient force to the button to overcome the resistive force of the element receiving force 106, the subject applies a level of force that is sufficient to suddenly and quickly insert the needle and cannula into the subject's skin. Fig. 78 shows the needle and cannula having been advanced because the button 80 was pushed with a force that exceeds the limit force.

[00122] Pushing the button 80 with sufficient force makes the structural element 103 advance to the individual's skin. When the structural element arrives at the end of its displacement, it is held in place by the retaining part 108. For example, a proximal part of the protuberance 104 can be secured by a force distally applied to it by a distal part of the receiving force 106, which constitutes the retaining part 108, as shown in figure 78. When the individual releases the button 80, as shown in figure 7C, a spring 11 O pushes the button upwards, which retracts the needle 102 back into the housing base 32. The cannula 100 coupled to the structural element 103, which is held in place by the retaining part 108. Therefore, the cannula remains inserted into the patient's skin. The substance is administered by the individual through the cannula.

[00123] In an alternative modality, the substance is administered by the individual through needle 102, the needle remaining inserted in the individual's skin for the duration of administration. In such an embodiment, apparatus 20 is typically configured to deliver substantially all of the substance to the subject in less than an hour. For example, Copaxone® (or another drug) can be administered to the subject in this way for approximately half an hour.

[00124] In some embodiments, needle 102 comprises a plurality of microneedles, which are inserted into the individual's skin, and the substance is administered to the individual via microneedles. Typically, the diameter of each microneedle is about 50-150 microns, for example, 100 microns, and the length of each microneedle is about 200-1000 microns.

[00125] In one embodiment, the control unit 51 is configured to receive an indication, on the bottle 22, first threaded element 26, second threaded element 28, or another element, which indicates a characteristic of the contents of the bottle 22. For example, a bar code, RFID, mechanical code, or other code can indicate to the control unit the type of pharmaceutical product in the bottle, the quantity of the substance, or a dosing schedule for the administration of the substance. Typically, when the individual first receives the vial, the plug 24 is already in place inside the vial in the correct position to start dispensing the substance.

[00126] Reference is now made to Figures 8A-B, which are schematic illustrations of the respective views of vial 22, according to an embodiment of the present invention. For some applications, a protrusion 120 protrudes from the inner surface 122 of the bottle, and the second threaded element 28 is a nut that is shaped to define a groove 124 on its outer surface.

When the nut advances to the distal end of the bottle, the groove 124 slides along the protuberance 120, preventing the nut from turning. Alternatively or additionally, the plug 24 is shaped to define a groove on its outer surface, the groove preventing the breadboard, and therefore the second threaded element, from rotating. In some embodiments, the inner surface 122 of the flask 22 is not round, but, for example, it is square, oval or rectangular. The outer surface of the second threaded element, and / or the plug, is shaped similarly to the inner surface of the bottle. The shapes of the inner surface 122, and the outer surface of the second threaded element and / or the plug, prevent the second threaded element from rotating.

[00127] In some embodiments, vial 22 contains (for example, the vial may be composed of) a cyclic olefin polymer, such as Crystal Zenith®. In some embodiments, fabricating the flask using a cyclic olefin polymer facilitates the shaping of the protuberance 120. For some applications, plug 24 is coated with fluoropolymer. Typically, using a vial that contains a cyclic olefin polymer, and / or a buffer that is coated with fluoropolymer maintains the stability of a substance that is disposed within the vial. For example, the vial can be used to deliver a monoclonal antibody to the individual, and the composition of the vial, the plug and / or the second threaded element can maintain the stability of the monoclonal antibody.

[00128] In some embodiments, the proximal end of the flask 22 is shaped to define two or more flanges 123. Typically, flanges facilitate filling of the flask. For example, when filling the bottle, the bottle can be placed inside a hole in a tray, and the flanges can support the bottle inside the hole. In some embodiments, the flanges are configured to hold the bottle in a fixed position within the housing base 32.

[00129] Reference is now made to figures 9A-B, which are schematic illustrations of bottle 22, according to one embodiment of the present invention. In some embodiments, the vial contains a distal compartment 130, and a proximal compartment 132, a divider cap 132 inhibiting fluid communication between the proximal and distal compartments. In some embodiments, a powder (for example, medication that is in the form of a powder) is disposed in the distal compartment 130 and a liquid (for example, water, saline and / or a medication) is disposed in the proximal compartment 132. when the second threaded element 28 is advanced distally through the bottle, the divider plug 134 is advanced distally. The advancement of the divider cap exposes compartment 132 to conduit 136. When the second threaded element 28 is advanced further, the plug 24 flows liquid into the distal compartment 130 through the conduit, in the direction of arrow 138 (as shown in figure 98). The liquid and powder then mix and, for example, can form a solution or a suspension, before being administered to the individual. In some embodiments, a first liquid medication is disposed in the distal compartment 130 and a second liquid medication is disposed in the proximal compartment 132. The divider plug 134 inhibits fluid communication between the first and second modifications. When the second threaded element 28 advances through the vial, the two measurements are mixed before being administered to the individual.

[00130] Reference is now made to figures 10A_B which are schematic illustrations of vial 22, according to an embodiment of the present invention. The vial contains a distal compartment 130, and a proximal compartment 132, the divider cap 134 inhibiting fluid communication between the proximal and distal compartments. In some embodiments, a medication is disposed in the distal compartment, and a washing solution, such as water or saline solution, is disposed in the proximal compartment. When the second threaded element 28 is advanced distally through the vial, the divider plug 134 is advanced distally, thereby administering the drug arranged in the proximal compartment 130 to the individual.

[00131] When the divider cap 134 is advanced to a position towards the distal end 36 of the vial the washing solution flows through the duct 140 (in the direction of arrow 142) and washes the medication from the vial and / or the conduits of the appliance 20.

[00132] It is noted that the term "supply" as used here in the report and in the claims, in the context of supplying apparatus (for example, supplying a bottle), includes within its scope the apparatus being supplied by the apparatus user , and is not limited to the sale of the device.

[00133] Reference is now made to figure 11, which is a schematic illustration of bottle 22, according to an embodiment of the present invention. In some embodiments, the first threaded element 26 is a nut that is rotatable with respect to the flask 22. the second threaded element 28 is a screw that is threadably coupled to the nut and arranged at least partially within the nut. During the rotation of the nut, the linear movement of the nut with respect to the bottle is prevented (for example, by the part 34 of the housing base 32, shown in figure 4). During rotation of the nut, the screw is substantially rotationally immobile with respect to the bottle. Typically, the distal end of the screw is coupled to the plug 24 via the coupling surface 30, and the plug prevents rotation of the screw. Thus, during rotation of the nut, the screw and plug advance to the distal end 36 of the vial and deliver the substance to the subject from the vial.

[00134] In some embodiments (as shown in figure 11), the distal end of the second threaded element is disposed within the plug 24. Although figure 1 shows the distal end of the screw disposed within the plug, the scope of the present application includes having the distal end of any embodiment of the second threaded element disposed within the plug 24, according to any of the methods or apparatus described herein. For example, the second threaded element can be a nut, for example, as shown in figures 6A-D, the distal end of the nut being arranged inside the plug instead of being coupled to the proximal end of the plug, as shown in figures 6A- D. Typically, using a second threaded element that is disposed within the plug facilitates the use of a bottle having a shorter length that would be necessary if the second threaded element was not disposed within the plug.

[00135] Reference is now made to Figures 12A-B, which are schematic illustrations of vial 22 containing a telescopic screw 150, according to an embodiment of the present invention. The bottle 22 of figure 12 is in general similar to the bottle 22 described with reference to figure 11, except for the differences described here below.

[00136] In some embodiments, the second threaded element is a telescopic screw. The first threaded element, by rotation, extends the telescopic screw and advances the plug 24 and the distal end 152 of the telescopic screw to the distal end 36 of the bottle 22, according to the techniques described here above. In some embodiments, using a telescopic screw as the second threaded element facilitates the use of a shorter vial to administer a given amount of the substance that would be required if a non-telescopic screw, or nut, were used as the second threaded element. In some embodiments, a telescopic screw is used as the first threaded element, and a nut is used as the second threaded element.

[00137] Although a telescopic screw having two overlapping parts 154 and 156 is shown, the scope of the present invention includes using a screw having three or more overlapping parts as the second threaded element of bottle 22. Typically, the ratio of the length of the screw telescopic when fully extended to the length of the telescopic screw when fully contracted (as shown in figure 12) is 1.5: 1 to 2: 1.

[00138] In some embodiments, as shown in figure 128, a second threaded element (for example, a nut or screw) is used which is (a) telescopic, and (b) at least partially disposed within the plug 24. For example , figure 128 shows a telescopic screw, a distal end of which is disposed within the plug 24. Typically, using a second threaded element which is (a) telescopic, and (b) disposed at least partially within the plug 24 facilitates use a shorter fraction to deliver a given amount of the substance that would otherwise be needed, ceteris paribus.

[00139] Reference is now made to figure 13, which is a schematic illustration of vial 22 containing a telescopic nut 160, according to an embodiment of the present invention. For some applications, a telescopic nut, such as that described in US Patent 6,905,298 to Haring, is used as the first threaded element (configuration not shown} or as the second threaded element (as shown) inside the bottle 22. In a In this embodiment, the nut is configured in such a way that the frictional forces between a first part 164 and a second part 166 of the nut prevent the first and second parts from becoming disengaged from each other. the bolt and part 166 prevent the bolt and part 166 from becoming disengaged, for example, the threads on the distal part of the bolt on the inner surface of the part proximal part 166 may widen, such that part 166 cannot unscrew the screw.

[00140] Vial 22 of figure 13 is generally similar to vial 22 described with reference to figure 12, except that a telescopic nut, instead of a telescopic screw, is used as the second threaded element. Although a telescopic nut having two overlapping parts 164 and 166 is shown, the scope of the present invention includes using a nut having three or more overlapping parts as the second threaded element of the bottle 22.

[00141] Typically, the ratio of the length of the telescopic nut when fully extended to the length of the telescopic nut when fully contracted (as shown in figure 13) is 1.5: 1 to 2: 1.

[00142] Reference is now made to Figure 14, which is a schematic illustration of the apparatus 20 including a vial housing unit 170 and a separate needle housing unit 172, according to an embodiment of the present invention. The apparatus shown in figure 14 is generally similar to the apparatus shown in figures 1 and 2, except for the differences described here below.

[00143] In some embodiments, the activation mechanism 56 is housed in the needle housing unit 172. The activation mechanism, as described here above, inserts the cannula 100 and / or the needle 102 through the subject's skin and distributes the substance through the cannula and / or the needle.

[00144] Vial 22 and control components, such as motor 50 and battery 58, are housed separately in vial housing unit 170. In some embodiments, needle housing unit 172 is adhered to the subject's skin, and the vial housing unit 170 is not adhered to the subject's skin. Typically, the needle housing unit and the bottle housing unit are not rigidly connected to one another. For example, vial housing unit 170 can be worn on the individual's belt, or anywhere else on the individual's clothing. Typically, the vial housing unit 170 is coupled to the needle housing unit 172 by means of tube 53, through which the substance flows from the vial to the activation mechanism 56.

[00145] It is noted that, although a specific configuration of the activation mechanism 56 is shown, in some embodiments, the needle housing unit 172 houses an activation mechanism having a different configuration. For example, the needle housing unit 172 can accommodate only the cannula 100 and / or the needle 102. The individual inserts the needle into the subject's skin, adhering the needle housing unit to the skin.

[00146] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described here above. Rather, the scope of the present invention includes both combinations and subcombination of the various aspects described here above, as well as variations and modifications of the same that are not in the prior art, which would occur to persons skilled in the art in reading the preceding description.

Claims (46)

1. An apparatus for administering a substance to an individual, comprising: a housing base (32) a vial (22) comprising a circular drum and containing the substance; a plug (24) inside the bottle (22), slidably coupled to the bottle (22); a first threaded element (26) rotatable with respect to the bottle (22) and linearly immobilized in a proximal direction with respect to the bottle (22) during the rotation of the first threaded element; and a second threaded element (28) which is threadedly coupled to the first element, at least one end of the second threaded element (28) without being rotatable with respect to the vial (22), the distal end of the second threaded element (28) defining a coupling part that couples the second threaded element (28) to the plug (24), and the first threaded element (26), by rotation, linearly advancing the plug (24) and at least the distal end of the second threaded element ( 28) towards a distal end of the bottle (22), the friction between the plug (24) and an internal surface of the bottle (22) preventing the rotation of the second threaded element (28) while allowing the distal movement of the second threaded element , and the vial (22) and the first and second threaded elements (26, 28) being configured to be inserted into the housing base (32), and in which a part of the housing base (32) is configured to prevent movement linear proximal of the first element then threaded (26) during the rotation of the first threaded element (26), the apparatus being characterized by the fact that a part of the housing base (32) is configured to displace the threaded elements (26, 28) and the plug (24 ) towards the distal end of the vial (22) during insertion into the housing base (32) and part of the housing base (32), and a vial piercing mechanism (44) is movably coupled to the base of the housing (32) and a part of the housing base (32) is configured to move the first and second threaded elements (26, 28) and the plug (24) towards the distal end (36) of the bottle (22) during insertion into the housing base (32). 2. Apparatus according to claim 1, characterized by the fact that the first threaded element (26) comprises a thread that defines a maximum diameter and a pitch, and a ratio between the maximum diameter and the pitch is 6: 1 to 15: 1. Apparatus according to claim 1, characterized in that the distal end of the second threaded element (28) is arranged at least partially within the plug (24). 4. Apparatus according to claim 1, characterized by the fact that the second threaded element (28) is configured to be coupled to the plug (24) by a user. 5. Apparatus according to claim 1, characterized by the fact that the second threaded element (28) is supplied to a user, the second threaded element (28) already coupled to the plug (24). Apparatus according to claim 1, characterized in that the vial (22) comprises a circular drum having an internal surface (122) that is smooth. Apparatus according to claim 1, characterized in that a distal end of the first threaded element (26) remains proximal to a proximal end of the plug (24) every time during the rotation of the first threaded element (26) . Apparatus according to claim 1, characterized in that it further comprises: a dividing plug (134) inside the vial (22), slidably coupled to the vial (22); wherein the vial (22) comprises a distal compartment (130) and a proximal compartment (132), the distal compartment (130) containing a powder and the proximal compartment (132) containing a liquid, the dividing plug (134) inhibiting reversibly the fluid communication between the distal compartment (130) and the proximal compartment (132), and where the first threaded element (134), by rotation, mixes the powder and the liquid advancing the dividing plug (134) in the direction of distal end of the vial (22). Apparatus according to claim 1, characterized in that the distal end of the second threaded element (28) is configured to remain proximal to a distal end of the plug (24) every time during the rotation of the first threaded element (26). Apparatus according to claim 1, characterized in that it further comprises: a bottle housing unit (170) which houses the bottle (22) and the threaded elements; a needle housing unit (172) coupled to the bottle housing unit (170) and without being rigidly connected to the housing unit; a needle (102) housed within the needle housing unit (172); and a cannula (100) disposed at least partially around the needle (102), in which the apparatus is configured to administer the substance to the individual via the cannula (100). Apparatus according to any one of claims 1 to 9, characterized in that the part of the housing base (32) is configured to apply a sufficient force, when displacing the threaded elements and the plug (24), to overcome the friction between the plug (24) and the vial (22) which is due to the prolonged storage of the plug (24) in contact with the vial (22). Apparatus according to any one of claims 1 to 9, characterized in that it further comprises a cannula (100) coupled to the housing base (32) and configured to be inserted into the skin of the individual, wherein the housing base ( 32), when moving the threaded elements and the plug (24), it is configured to expel gas through a distal end of the cannula (100). 13. Apparatus according to claim 12, characterized in that the part of the housing base (32), when displacing the threaded elements and the plug (24), is configured to expel at least some of the substance through the end distal cannula (100). Apparatus according to any one of claims 1 to 9, characterized in that the part of the housing base (32) is arranged with respect to a part at a proximal end of the vial (22) such that, during insertion of the bottle (22) and the threaded elements in the housing base (32), the relative movement between the part of the housing base (32) and the part at the proximal end of the bottle (22) displaces the threaded elements and the plug ( 24) towards the distal end of the vial (22). Apparatus according to claim 14, characterized in that the part of the housing base (32) is arranged such that the sliding movement between the part of the housing base (32) and the part at the proximal end of the bottle (22) advances the threaded elements and the plug (24) towards the distal end of the bottle (22). Apparatus according to any one of claims 1 to 9, characterized in that it further comprises: at least one gearwheel (54) which is attachable to a proximal end of the first threaded element (24) and configured to rotate the first threaded element (26) per rotation; a motor (50) configured to turn the sprocket (54); and a housing top (48), to which the sprocket (54) and the motor (50) are coupled. Apparatus according to claim 16, characterized in that it additionally comprises a control unit (51) coupled to the motor (50), in which the control unit (51) is configured to receive a coded indication of a characteristic of the substance , and to control the engine (50) in response to the indication of the characteristic of the substance. 18. Apparatus according to claim 16, characterized by the fact that it comprises a control unit (51) coupled to the motor (50), in which the control unit (51) is programmable and is configured to be programmed to administer a basal rate of the substance to the individual when controlling the engine (50). 19. Apparatus according to claim 16, characterized in that it additionally comprises a control unit (51) coupled to the motor (50), in which the control unit (51) is configured to receive an input and to administer a bolus of the substance to the individual in response to entry. 20. Apparatus according to claim 16, characterized in that it further comprises: a control unit (51) coupled to the motor (50); and a sensor (57) configured to detect an individual's physiological parameter and transmit a signal to the control unit (51) in response to the parameter, and in which the control unit (51) is configured to control the motor (50) in response to the signal. 21. Apparatus according to claim 20, characterized by the fact that the sensor (57) is configured to be implanted in the individual's body. 22. Apparatus according to claim 20, characterized by the fact that the sensor (57) is configured to transmit the signal wirelessly. 23. Apparatus according to claim 20, characterized in that the housing base (32) is configured to hold the bottle (22), wherein the housing base (32) and the housing top (48) are configured to be coupled together by the individual before administration of the substance, and decoupled from each other by the individual after administration of the substance. 24. Apparatus according to claim 23, characterized by the fact that: the top of the housing (48) is configured to be reused subsequent to the administration of the substance in the vial (22), and in which the base of the housing (32) and the threaded elements are configured to be discarded following the administration of the substance from the vial (22). Apparatus according to claim 23, characterized in that it further comprises: one or more magnetic elements coupled to the housing base (32); and one or more magnetic elements coupled to the top of the housing (48), and wherein the magnetic elements are configured to magnetically reversibly couple the housing base (32) to the top of the housing (48) when the housing base (32 ) and the top of the housing (48) are aligned. 26. Apparatus according to any one of claims 1 to 9, characterized by the fact that: the bottle (22) and the threaded elements are configured to be inserted into the housing base (32); a needle coupled to the housing base (32); and a cannula (100) at least partially arranged around the needle, where the needle is configured to pierce the subject's skin and insert the cannula (100) into the subject's skin, where the needle is configured to retract after the perforation, and in which the apparatus is configured to administer the substance to the individual through the cannula (100). 27. Apparatus according to claim 26, characterized in that it further comprises a needle activation mechanism coupled to the needle (102), the needle activation mechanism comprising: a contact surface with the individual to apply a force to it by the individual; and a force receiving element that is configured to be displaced when the force applied by the subject on the contact surface with the subject exceeds a limit force, and where the needle (102) is configured to rapidly puncture the skin in response to displacement of the force receiving element due to the force exceeding the limit force. 28. Apparatus according to claim 27, characterized in that it further comprises a spring (110), wherein the spring (110) is configured to retract the needle after drilling (102). 29. Apparatus according to any of claims 1 to 9, characterized by the fact that: the bottle (22) and the threaded elements are configured to be inserted into the base of the housing (32); and a needle (102) coupled to the housing base (32) and configured to pierce the individual's skin, and wherein the apparatus is configured to deliver the substance to the individual via the needle (102). 30. Apparatus according to claim 29, characterized by the fact that the apparatus is configured to administer the entire substance in less than an hour. 31. Apparatus according to any one of claims 1 to 9, characterized by the fact that: the bottle (22) and the threaded elements are configured to be inserted into the housing base (32); and a plurality of microneedles coupled to the housing base (32) and configured to pierce the individual's skin, and wherein the apparatus is configured to deliver the substance to the individual by means of the plurality of microneedles. 32. Apparatus according to claim 31, characterized in that the diameter of each microneedle is less than 150 microns. 33. Apparatus according to any of claims 1 to 10, characterized in that the first threaded element (26) comprises a screw, and the second threaded element comprises a nut at least partially arranged around the screw. 34. Apparatus according to claim 33, characterized in that the screw comprises a telescopic screw, and in which the screw is configured to advance a distal end of the nut towards the distal end of the bottle (22) when extending the telescopic screw to the distal end of the bottle (22). 35. Apparatus according to claim 34, characterized in that the telescopic screw comprises two parts at least partially overlapping. 36. Apparatus according to claim 34, characterized in that the telescopic screw comprises three or more parts at least partially overlapping. 37. Apparatus according to claim 33, characterized in that the nut comprises a telescopic nut, and the screw is configured to advance a distal end of the nut towards the distal end of the bottle (22) by extending the telescopic nut towards the distal end of the bottle (22). 38. Apparatus according to claim 37, characterized in that the telescopic nut comprises two parts at least partially overlapping. 39. Apparatus according to claim 37, characterized in that the telescopic nut comprises three or more parts at least partially overlapping. 40. Apparatus according to any one of claims 1 to 10, characterized in that the first threaded element (26) comprises a nut, and the second threaded element (28) comprises a screw at least partially disposed within the nut. 41. Apparatus according to claim 40, characterized in that the screw comprises a telescopic screw, and in which the nut is configured to advance a distal end of the screw towards the distal end of the bottle (22) extending the screw telescopic to the distal end of the vial (22). 42. Apparatus according to claim 40, characterized in that the telescopic screw comprises at least partially overlapping two parts. 43. Apparatus according to claim 41, characterized in that the telescopic screw comprises three or more parts at least partially overlapping. 44. Apparatus according to claim 40, characterized in that the nut comprises a telescopic nut, and in which the nut is configured to advance a distal end of the screw to the distal end of the bottle (22) by extending the nut telescopic towards the distal end of the vial (22). 45. Apparatus according to claim 44, characterized in that the telescopic nut comprises two parts at least partially overlapping. 46. Apparatus according to claim 44, characterized by the fact that the telescopic nut comprises three or more at least partially overlapping parts.